MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070350-48

Device Problems Stretched (1601); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the implanted stent interacted with the balloon catheter during post dilation causing the reported stretched stent and device damaged by another.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the moderately tortuous, 90% stenosed mid left anterior descending coronary artery.A non-abbott atherectomy device was used along with a non-abbott 2.5x15mm balloon at 20 atmospheres (atms) and another non-abbott 3x10mm balloon at 20 atms for pre-dilatation.A 3.5x48mm xience xpedition stent was deployed at 10atms, and a non-abbott 3.5x15mm non-compliant balloon was used at 28 atms for post-dilatation.It was confirmed by intravascular ultrasound that the stent had elongated 2-3mm due to the post-dilatation.No treatment or intervention was performed to treat the elongated implanted stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded the following: i am unable to determine visually, if there is actual elongation of the stent as this would only be possible to see using intra-vascular imaging, specifically oct while using a high resolution 54 mm pullback technique which would allow for appropriate resolution for stent rendering that is detailed and accurate enough to make a clear judgement on stent elongation.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9575734
• MDR Text Key: 177808146
• Report Number: 2024168-2020-00547
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2022
• Device Catalogue Number: 1070350-48
• Device Lot Number: 9061441
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 69